Acalabrutinib - Generic Drug Details
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What are the generic sources for acalabrutinib and what is the scope of patent protection?
Acalabrutinib
is the generic ingredient in one branded drug marketed by Astrazeneca and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Acalabrutinib has one hundred and fifty-nine patent family members in forty-eight countries.
One supplier is listed for this compound.
Summary for acalabrutinib
International Patents: | 159 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 44 |
Clinical Trials: | 130 |
Patent Applications: | 1,527 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for acalabrutinib |
What excipients (inactive ingredients) are in acalabrutinib? | acalabrutinib excipients list |
DailyMed Link: | acalabrutinib at DailyMed |
Recent Clinical Trials for acalabrutinib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Kite, A Gilead Company | Early Phase 1 |
Acerta Pharma, LLC | Early Phase 1 |
Jeremy Abramson, MD | Phase 2 |
Pharmacology for acalabrutinib
Drug Class | Kinase Inhibitor |
Mechanism of Action | Tyrosine Kinase Inhibitors |
Paragraph IV (Patent) Challenges for ACALABRUTINIB
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CALQUENCE | Capsules | acalabrutinib | 100 mg | 210259 | 5 | 2021-11-01 |
US Patents and Regulatory Information for acalabrutinib
EU/EMA Drug Approvals for acalabrutinib
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
AstraZeneca AB | Calquence | acalabrutinib | EMEA/H/C/005299 Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. |
Authorised | no | no | no | 2020-11-05 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for acalabrutinib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2007509060 | See Plans and Pricing | |
Serbia | 58177 | 4-IMIDAZOPIRIDAZIN-1-IL-BENZAMIDI I 4-IMIDAZOTRIAZIN-1-IL-BENZAMIDI KAO INHIBITORI BTK (4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES AS BTK-INHIBITORS) | See Plans and Pricing |
South Korea | 101802689 | See Plans and Pricing | |
Japan | 2018035184 | BTK阻害剤としての4−イミダゾピリダジン−1−イル−ベンズアミドおよび4−イミダゾトリアジン−1−イル−ベンズアミド (4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES AS BTK INHIBITORS) | See Plans and Pricing |
Norway | 2021016 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for acalabrutinib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2734522 | 21C1014 | France | See Plans and Pricing | RODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1479 20201106 |
2734522 | 2021C/512 | Belgium | See Plans and Pricing | PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106 |
2734522 | PA2021004 | Lithuania | See Plans and Pricing | PRODUCT NAME: AKALABRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1479/001-EU/1/20/1479/002 20201105 |
2734522 | 2021016 | Norway | See Plans and Pricing | PRODUCT NAME: AKALABRUTINIB; REG. NO/DATE: EU/1/20/1479 20201111 |
2734522 | LUC00202 | Luxembourg | See Plans and Pricing | PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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